Forum
U.S. Supreme Court
Case Status
Decided
Docket Number
06-1498
Term
2007 Term
Oral Argument Date
February 25, 2008
Questions Presented
1. Whether, under the conflict preemption principles in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), federal law preempts state law to the extent that it requires the fact-finder to determine whether the defendant committed fraud on a federal agency that impacted the agency’s product approval, where the agency—which is authorized by Congress to investigate and determine fraud—has not found any such fraud, and thus—as in Buckman—the state requirement would interfere with the agency’s critical functions.
2. Whether, under the conflict preemption principles in Buckman, federal law preempts the provision in a Michigan statute that allows a product liability claim to be maintained against a manufacturer of an FDA approved drug where, without an FDA finding of fraud on that agency, the fact-finder is required to make a finding under state law as to whether the manufacturer committed fraud-on-the-FDA and whether, in the absence of that fraud, the FDA would not have approved the drug.
Case Updates
Supreme Court rules on federal preemption of state efforts to police fraud on a federal agency
March 03, 2008
An equally-divided Supreme Court affirmed the decision below that federal law does not preempt a Michigan statute that affords a pharmaceutical manufacturer complete immunity against a product liability action if it can demonstrate that the allegedly defective product received the Food and Drug Administration’s approval, unless the approval was obtained by fraud. Because the Supreme Court decision was equally split, the Court’s opinion has no precedential value and confusion may persist among the lower courts.
U.S. Chamber files amicus brief on the merits
November 27, 2007
NCLC urged the Supreme Court to clarify once and for all that the presumption against preemption simply does not apply to the analysis of whether state law conflicts with federal law. By statute, Michigan law affords a pharmaceutical manufacturer complete immunity against a product liability action if it can demonstrate that the allegedly defective product at issue received the Food and Drug Administration’s approval. This statutory immunity does not apply, however, if the plaintiff can demonstrate that the manufacturer made any misrepresentations in the course of obtaining approval. The court below applied the presumption against preemption, finding that the Michigan statute did not conflict with federal law. In addition to attacking the presumption against preemption’s place in conflict preemption analysis, NCLC also relied on the Court’s precedent in Buckman Co. v. Plaintiffs’ Legal Committee for the proposition that states are not permitted to police fraud on a federal agency